Clinical Program Management Director

Role description:
•    A global role within Global Development Operations (GDO) based in Ireland
•    Reports (at a minimum) to: CPO TA Head.

Responsible for:
•    Global clinical program operational strategy, planning, risk assessment and mitigation, and overall execution
•    High-quality execution of clinical trials on time and within budget
•    Leadership of the Global Clinical Studies Team (GCST) for the allocated program(s)
•    Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan (EGP) and PT as required
•    Providing clinical operations leadership and expertise in EGP execution through the feasibility and study design process 
•    Development and oversight of clinical program budgets in collaboration with TA and Finance
•    Managing program-level operational issues and oversight of study team issue escalation
•    Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management
•    Representing CPO on process improvement initiatives
•    Support CPO resource planning for assigned program(s) in collaboration with Program Resource Management (PRM) 
•    Line management of CPO CPM-SMs / ADs

Purpose / Accountabilities
•    Global single point of accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs
•    Support continuous improvement initiatives in CPO and throughout Global Development Operations (GDO)

Key Activities 
•    Oversee the operational design, planning and execution of all studies for the program
•    Oversee the development of timelines and budgets for studies within the program
•    Oversee people management, career development, training and succession planning of CPO Senior Managers and Associate Directors
•    Oversee structure and engagement of program CPO team
•    Input into product Clinical Development Planning (CDP) and evidence generation plans
•    Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers
•    Contribute operational expertise throughout study design coordinating cross functional input on a continuous basis 
•    Provide advice on development of Key Design Elements (KDE) prior to Governance Body review
•    Provide visibility to study cost drivers and assumptions as refined throughout KDE and protocol development
•    Lead cross-functional team to create and periodically review/revise program & study Clinical Trial-Risk Assessment Categorization Tool (CT-RACT)
•    Evaluate if “Patient Voice” techniques should be incorporated on program and design, implement and measure the success of subject Recruitment and Retention Strategies
•    Accountable for study global enrolment plans, revised enrolment plans and accurate global recruitment forecasting
•    Support the resolution of cross-functional program issues escalated from the study teams and GCST and inform / escalate to TA Head and other stakeholders as appropriate
•    Leads the GCST to ensure operational consistency and standards across all clinical studies within the program
•    Communicate effectively with key stakeholders the program strategy and deliverables 
•    Contribute to functional goal setting
•    Facilitate sharing of best practices, product knowledge and identify areas for process improvement within CPO
•    Review vendor evaluation to include identification of outsourcing requirements for study / program and oversee management of vendors.
•    Supports and oversees internal audit and inspection activities and contributes to CAPAs globally for the program 
•    Lead planning for regulatory agency inspection readiness activities (e.g. TMF review) and ensure execution of plans
•    Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution. Contribute to development and maintenance of policies, SOPs and associated documents
•    Oversee the development of study diversity plans and ensure program actively engaging in DI&B strategies.

Qualifications
Basic Qualifications
•    Doctorate degree & 4 years of directly related experience or equivalent 
OR
•    Master’s degree & 8 years of directly related  experience or equivalent 
OR
•    Bachelor’s degree & 10 years of directly related experience or equivalent 
AND
•    4 years of direct managerial and/or leadership experience or equivalent 

Preferred Qualifications
•    PhD, PharmD, MSc., B.Sc., R.N
•    11 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
•    Previous management experience of direct reports, including management level staff
•    Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

Knowledge
•    Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting
•    Project and Program management including oversight of study deliverables, budgets and timelines
•    Time, cost and quality metrics
•    Relevant operational expertise
•    Understanding of resource management and organizational capacity management
•    Experience in developing goals and training plans to maximize talent and career development of staff
•    Experience of managing projects in a matrix organization
•    Ability to network and build relationships to maximize organizational and functional capabilities
•    Experience in leading organizations through change
•    Relevant therapeutic knowledge.

Key Competencies
•    Departmental Leadership
•    People Management
•    Project Management
•    Matrix team leadership
•    Strategic Operational Planning
•    Relationship Management and negotiation and influencing skills
•    Risk assessment/ risk mitigation
•    Innovation
•    Decision Making and Problem Solving
•    Conflict Management
•    Oral and Written Communication
•    Scientific / Technical Excellence
•    Financial Management
•    Flexibility / Adaptability.